People with diabetes using a particular type of insulin pump and pre-filled insulin cartridges should insert their cartridges correctly to avoid them leaking and potentially giving an under-delivery of insulin. This can lead to high blood glucose (hyperglycaemia) and can have serious health implications.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued this advice after feedback to the manufacturer, Roche Diabetes Care, from people who were experiencing leaking insulin cartridges.
Users of Accu-Chek Insight insulin pump system with NovoRapid PumpCart cartridges, can check for any leaked insulin in the cartridge compartment by regularly checking the pump a few hours after changing the cartridge as any leaked insulin would be visible.
John Wilkinson, MHRA’s Director of Medical Devices, said:
It’s important that cartridges are correctly inserted into these pumps to ensure you receive the correct level of insulin.
You should take care when changing cartridges to make sure they do not leak, reducing the amount of insulin being delivered.
We continue to encourage people to report any issues involving medical devices to MHRA via our Yellow Card Scheme.
Dan Howarth, Head of Care at Diabetes UK, said:
Ensuring the correct level of insulin is vitally important in the management of diabetes.
If you have any questions about your level of insulin you should consult with your diabetes care team.
Please see the link to the Medical Device Alert.
See the Field Safety Notice (FSN) for detailed handling steps when inserting or changing a pre-filled insulin cartridge.
To report a suspected problem or incident with a medicine or a medical device please visit the Yellow Card Scheme website.
MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk